Product Complaints Management

Ensure Compliance. Elevate Patient Safety. Streamline Investigations.

Struggling with increasing volumes of medical device complaints or navigating complex global regulations like EU MDR and FDA MDR/SMDR?
Freyr’s end-to-end medical device complaints management solutions support you from complaint intake and triage to regulatory complaint investigation and adverse event reporting. Whether it's high-risk product defect handling, vigilance reporting, or translation services, we help you stay compliant, responsive, and ready always.

Optimize your complaint management system with Freyr, because every complaint is an opportunity to improve safety and trust.

Product Complaints Management Overview

Establishing a structured medical device complaints-handling process is a mandatory requirement for manufacturers to ensure the safety, efficacy, and quality of their products, to meet Regulatory compliance and effective adverse event reporting.

Freyr’s Complaints management experts help medical device manufacturers in optimizing their complaint management system by maintaining consistent complaints investigation process starting from intake and triaging, evaluation, investigation, vigilance reporting, and closure of complaints. We help clients improve user experience by responding swiftly to customer feedback, support high volume fluctuation of complaints, ensuring timely submission of reports of product defects and adverse events to government authorities.

Product Complaints Management Expertise and Advantages

  • Intake, Triaging, Evaluation, Investigation & Closure
  • Vigilance reporting
  • Medical device reporting (MDR)
  • Supplemented medical device reporting (SMDR)
  • Reason to report documentation
  • EU MDR and OUS reporting
  • Intelligent dashboard reporting
  • Language translation
  • Dedicated SMEs
  • In-depth product and Regulatory knowledge and expertise to understand complex device issues and identify underlying problems
  • Seasoned PMS experts ensure consistent complaints investigation process
  • Flexibility in the team to handle volume fluctuations
  • Experience across a wide range of therapeutic areas and digital platforms
  • Expert translators and language specialists simplify complex technical jargon

Why Partner with Freyr?